PiCCO ASSESSMENT IN PATIENTS WITH SEPTIC SHOCK

NCT ID: NCT05271032

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-05-01

Brief Summary

Sepsis is the result of a complex pathological process which involves an intravascular inflammatory state, loss of vascular tone, endothelial injury, extravascular leakage, and often inefficient myocardial contractility. These affect the cardiovascular homeostasis as well as the regional perfusion and tissue oxygenation of patient. The importance of early cardiovascular support in septic patients is the reason why, for about fifteen years, the implementation of standardized resuscitation protocols has been emphasized.

The Surviving Sepsis Campaign Guidelines (SSG) recommend an initial fluid resuscitation followed by use of a vasoactive agent such as norepinephrine for the treatment of patients with septic shock. To understand the impact of the hemodynamic support provided by the resuscitation strategy, the assessment of surrogate clinical parameters is pivotal. According to the current guidelines, the increase of mean arterial pressure (MAP) above 65 mmHg represents the threshold in defining patients as "stable".

Although this strategy has been well established, its impact on the actual hemodynamic profile of the septic patient, remains a subject of ongoing controversy. In this scenario, the transpulmonary thermodilution technique (TPTD) allows invasive assessment of the patient hemodynamic profile in terms of fluid responsiveness, vasomotor status, or global cardiac efficiency. By using this technique, several studies highlighted a wide variability in the individual response of patients undergoing cardiovascular stabilization guided by SSG. This suggests that the implementation of a "customized" resuscitation protocol based TPTD derived parameters rather than resuscitation strategy guided by a fixed mathematic model, could be preferred. However, in daily clinical practice, the use of this advanced hemodynamic monitoring system in not routinely used, though it is often reserved in case of failure of the initial SSG-resuscitation protocol.

The investigators supposed that, even if the initial resuscitative efforts were successful in achieving the SSG targets i.e. by restoring the MAP > 65 mmHg, this could still be inadequate in some patients. Accordingly, the investigators hereby will report the hemodynamic profile of patients with septic shock admitted in ICU.

Conditions

Septic Shock

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Septic Patients

use of Trasnpulmonary termodiluetion technique

Intervention Type: DIAGNOSTIC_TEST

All the patients underwent to invasive hemodynamic monitoring through the transpulmonary thermodilution technique (PiCCO, PULSION medical system. Gettinge; Solna, Sweden). Briefly, the technique consists in the administration of a cold saline bolus in superior vena cava while monitoring the corresponding temperature variation through a femoral arterial catheter equipped with a tip thermistor. Accordingly, a 5 French catheter equipped with a tip thermistor was inserted into the femoral artery.

Interventions

use of Trasnpulmonary termodiluetion technique

All the patients underwent to invasive hemodynamic monitoring through the transpulmonary thermodilution technique (PiCCO, PULSION medical system. Gettinge; Solna, Sweden). Briefly, the technique consists in the administration of a cold saline bolus in superior vena cava while monitoring the corresponding temperature variation through a femoral arterial catheter equipped with a tip thermistor. Accordingly, a 5 French catheter equipped with a tip thermistor was inserted into the femoral artery.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Picco

Eligibility Criteria

Inclusion Criteria

• older than 18 years
• admitted in ICU with diagnosis of septic shock

Exclusion Criteria

• Contraindication at the insertion of the PiCCO catheter; conditions able to bias the transpulmonary thermodilution technique results (atrial fibrillation, extracorporeal membrane oxygenation, valvular disease and/or cardiomyopathy
• Pre-existing respiratory and cardiovascular pathologies
• Pre-existing kidney pathologies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Salvatore Grasso

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Salvatore Grasso

Bari, , Italy

Countries

Italy

Other Identifiers

TPTD_CFI01

Identifier Type: -

Identifier Source: org_study_id